cqi and pdca for sterile compounding pharmacies

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Introduction to CQI for managers and operators of sterile compounding pharmacies.

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Page 1: CQI and PDCA for Sterile Compounding Pharmacies

Willis C. Triplett, Pharm.D.Friday, April 7, 2023

Continuous Quality Improvement For Sterile Compounding Pharmacies

Page 2: CQI and PDCA for Sterile Compounding Pharmacies

USP Chapter <797> states:“A provider of CSPs shall have in place a formal QA program intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes described in this chapter. Emphasis in the QA program is placed on maintaining and improving the quality of systems and the provision of patient care. In addition, the QA program ensures that any plan aimed at correcting identified problems also includes appropriate follow-up to make certain that effective corrective actions were performed.”

USP Chapter <797>

Page 3: CQI and PDCA for Sterile Compounding Pharmacies

USP Chapter <797> further states that characteristics of the QA Program shall include:1. Formalization in writing; 2. Consideration of all aspects of the preparations and dispensing of products

as described in this chapter, including environmental testing and verification results;

3. Description of specific monitoring and evaluation activities; 4. Specification of how results are to be reported and evaluated; 5. Identification of appropriate follow-up mechanisms when action limits or

thresholds are exceeded; and6. Delineation of the individuals responsible for each aspect of the QA program.

USP Chapter <797>

Page 4: CQI and PDCA for Sterile Compounding Pharmacies

› Often abbreviated as “CQI”;› Refers to a PROCESS of IMPROVEMENT that reiterates

continuously – the moment it succeeds, it targets the next weakness and starts all over again from the beginning;

› The same steps are followed in the same order with each iteration of target problem-improvement;

› Those steps are “PLAN-DO-CHECK-ACT.”

Continuous Quality Improvement

Page 5: CQI and PDCA for Sterile Compounding Pharmacies

Continuous Quality Improvement

Plan-Do-Check-Act, is commonly abbreviated as PDCA

Page 6: CQI and PDCA for Sterile Compounding Pharmacies

› CQI based on the belief that, no matter how good a business process is, it can be improved, and that…

› …no matter what the current state of our process is, we can and should strive toward a new, higher performance target.

Continuous Quality Improvement

Page 7: CQI and PDCA for Sterile Compounding Pharmacies

Management notes that HIPAA violations are occurring too often

HIPAA violations found to center on pack and ship process

Pack and ship team members retrained

Outsourced pack and ship couriers retrained

HIPAA violations still occurring too often

HIPAA violations still occurring too often

HIPAA violation incidence falls by 90%

Pack and ship work flow redesigned

Example of CQI in action:

Page 8: CQI and PDCA for Sterile Compounding Pharmacies

› In essence, CQI is like scientific research on the enterprise’s own results;

› It is based on statistical evaluation and requires faithful compilation of accurate performance records. In most organizations, the source of such information will be the enterprise software;

› Each iteration of PLAN-DO-CHECK-ACT is an experiment to see if the problem has been remedied to an acceptable level of risk.

Continuous Quality Improvement

Page 9: CQI and PDCA for Sterile Compounding Pharmacies

› The PLAN revolves around picking the target that the team will improve;

› The target of the PLAN should be the system’s MOST CRITICAL WEAKNESS;

› The target is determined by a frank and (brutally) honest examination of the system’s failures;

Continuous Quality Improvement

Page 10: CQI and PDCA for Sterile Compounding Pharmacies

› The choice of target is based on a weighing of the difficulty of the improvement versus the importance of the failure.

Continuous Quality Improvement

(Vital) 109 A87 B6 E C54 F D32 G

(Trivial) 1 Z1 2 3 4 5 6 7 8 9 10

Very Diffi cult (Very Easy)

Impa

ct o

r Im

pora

tanc

e

Diffi culty

Among these choices,A would be the first target and B would be the second.

Life is probably too short to ever get to Z

Page 11: CQI and PDCA for Sterile Compounding Pharmacies

› Picking the right target is a vital management decision, since CQI resources are always limited.

› The PLAN must be focused on only one activity at a time within a given team. There can only be one “top priority” at a time.

› Management must maintain a laser-like focus on the success of the PLAN. It must never be forgotten or “lost in the shuffle”;

› The PLAN must make sense to the team’s workers and the goal must be desirable in their eyes. It will not succeed unless they see the need for it. Management should educate the team regarding “what it means to them.”

Continuous Quality Improvement

Page 12: CQI and PDCA for Sterile Compounding Pharmacies

› Once the target deficiency is chosen, the team meets to identify and rank the most likely root cause(s) of the problem;

› After consensus is reached regarding the root cause(s), the remedy is designed. In a large organization, the remedy should be tested in one site, one department, or one unit;

› The chosen unit is retrained to operate according to the remedial process. Once trained, the unit begins to “DO”.

Continuous Quality Improvement

Page 13: CQI and PDCA for Sterile Compounding Pharmacies

› The “DO” stage is the actual experiment on the remedy;› The test department begins to operate in the “new way,” and

the results are collected and compiled carefully for a prescribed period of time; (a week, a month, a quarter, etc.)

Continuous Quality Improvement

Page 14: CQI and PDCA for Sterile Compounding Pharmacies

Continuous Quality Improvement

› After sufficient data have been collected and compiled in the “DO” step, the results are analyzed in the “CHECK” step;

› The analysts contrast the actual results of the “new” process (the remedy) versus the historical results (“that’s the way we’ve always done it.”)

› The analysts and management determine whether the target has been acceptably met, nearly met, or not met nearly well enough;

Page 15: CQI and PDCA for Sterile Compounding Pharmacies

› If the remedy has achieved the target goal, it is accepted as the new way things will be done. (Adoption)– Policy and Procedures are altered to reflect the remedy (the “new way we do this”)– Existing staff will be retrained in the “new way” company-wide. – New hires will be taught according to the “new way.”;

› If the remedy caused improvement, but not enough to meet the goal, the “PLAN” team reconvenes to make further changes, and the “DO” step starts all over again; (Adaptation)

› If the remedy failed to cause any improvement in the target goal, the team starts all over again with a new “PLAN” step. (Abandonment)

Continuous Quality Improvement

Page 16: CQI and PDCA for Sterile Compounding Pharmacies

› So, the remedy worked and we’ve improved our process, memorialized it in policy, and adjusted our staff training. We’re done, right? Feet up on the desk? Time to kick back?

› Sadly, we only kick back if all of our other results are perfect. Otherwise, we identify our next-most-important problem and start another cycle of PDCA. Back to work!

Continuous Quality Improvement

Page 17: CQI and PDCA for Sterile Compounding Pharmacies

› PLAN-DO-CHECK-ACT always works;› PLAN-DO-CHECK-ACT does not always work the first time. In

creating the tungsten filament light bulb, Edison failed hundreds of times before he succeeded. He was asked if he hated “wasting his time,” with the hundreds of failures. His answer was that none of the hundreds of failures were a waste of time because each one showed that a proposed solution DID NOT WORK.

› What would really be a waste of time is trying the same non-working solution more than once.

Continuous Quality Improvement

Page 18: CQI and PDCA for Sterile Compounding Pharmacies

› PLAN-DO-CHECK-ACT is how we learn and grow. If you don’t believe me, just watch an infant moving to toddlerhood. Every step:– Rolling over;– Hands and knees;– Standing up by holding onto fixed objects;– Standing up without support;– Taking the first step;– Taking multiple steps;– Walking;– Running.

› …involves PDCA on the part of the infant. Every graduation involves goal-setting, experimentation, success/failure, evaluating results, contrasting against the “old way,” and changes in “policy.”

Continuous Quality Improvement

Page 19: CQI and PDCA for Sterile Compounding Pharmacies

› Questions, Comments, Criticism, Counterpoints?› To learn more about this topic contact Willis Triplett at:– [email protected]